Clinical Trial Protocol Iranian Registry of Clinical Trials

28 Sep 2021

Investigating the effect of handwash training on knowledge, attitude and manner of washing the hands of third grade elementary school student in city in 1394

Protocol summary manner of washing the hands of the third grade elementary school students in Tehran before and after Study aim handshake training in the intervention and control group Determining the effect of handwashing training program on knowledge, attitude and manner of washing hands of General information third grade elementary school students Design Reason for update This study is a semi-experimental study of a randomized Acronym clinical trial. Sixty-seven primary school students in IRCT registration information district 1 of Tehran were randomly divided into IRCT registration number: IRCT20181008041275N1 intervention and control groups using pre-test and post- Registration date: 2018-10-21, 1397/07/29 test. In order to collect data in both groups, an Registration timing: retrospective awareness-gauging questionnaire, attitude, and handwashing handwashing inventory were used. Last update: 2018-10-21, 1397/07/29 Settings and conduct Update count: 0 Selecting an area from randomly selected areas of Registration date education, choosing a randomly clustered area, choosing 2018-10-21, 1397/07/29 two boys and two girls' schools randomly and then randomly assigning a boys school and a girls' school as Registrant information an intervention group and a boys' And a girls' school in Name the control group and a random sampling of the third Maryam Mohamadi grade students of that school if that school has more Name of organization / entity than a third grade class. Country Participants/Inclusion and exclusion criteria (Islamic Republic of) maximum age of at least 8-10, a child or parent's Phone consent, not attending similar research, lack of +98 21 2286 3624 concentration disorders and none of the child's parents Email address are a member of the health staff. Exit criteria: Non- [email protected] attendance at one of the training sessions, the individual's or parents' dissatisfaction with continuing Recruitment status cooperation, the occurrence of any stressful events Recruitment complete during the implementation of the training program. Funding source Intervention groups 38 students from the 3rd grade elementary school Expected recruitment start date received hand-held instruction in 3 class sessions using 2016-05-15, 1395/02/26 posters, films and animations. 38 students were in the Expected recruitment end date control group and did not receive any training. 2016-05-17, 1395/02/28 Main outcome variables Actual recruitment start date Determining and comparing the knowledge, attitude and 2016-05-15, 1395/02/26

1 Actual recruitment end date evaluation checklist were used to collect information. All 2016-05-17, 1395/02/28 of them were researched and their validity and reliability Trial completion date were confirmed by the CVR test. 2016-06-07, 1395/03/18

Scientific title Secondary Ids Investigating the effect of handwash training on empty knowledge, attitude and manner of washing the hands of third grade elementary school student in tehran city in Ethics committees 1394

Public title 1 Investigating the effect of handwashing training on Ethics committee elementary school students Name of ethics committee Purpose University of Rehabilitation Sciences and Social Prevention Welfare Inclusion/Exclusion criteria Street address Inclusion criteria: University of Rehabilitation Sciences and Social Having a maximum of at least 10-8, a third grade Welfare,koodakyar st,daneshjoo primary school. Child or Parental Satisfaction Not Blvd,,Tehran,Iran participating in similar research Absence of disturbance City disturbances (autism and hyperactivity) None of the Tehran child's parents is a member of the health staff Province Exclusion criteria: Tehran Not attending one of the training sessions Dissatisfaction Postal code of the individual or parents to continue cooperation The ۱۹۸۵۷۱۳۸۳۴ occurrence of any stressful events during the Approval date implementation of the training program 2016-05-09, 1395/02/20 Age Ethics committee reference number From 8 years old to 10 years old IR.USWR.REC.1395.60 Gender Both Health conditions studied Phase N/A Groups that have been masked 1 No information Description of health condition studied Sample size Third grade elementary school students Target sample size: 70 ICD-10 code Actual sample size reached: 76 ICD-10 code description Randomization (investigator's opinion) Randomized 2 Randomization description Multi-stage sampling of Tehran's educational areas. At Description of health condition studied first, an area from among the educational districts was Age 8-9 randomly selected. Then, a randomly selected cluster ICD-10 code area was selected from among its areas. The choice of ICD-10 code description two male schools and two girls' schools were randomly assigned and then randomized to a boys' school and a Primary outcomes girls' school as an intervention group and a boys' school and a girls' school in the control group and random sampling from their third grade school students if they 1 That school had more than a third grade class. Description Blinding (investigator's opinion) Attitude Not blinded Timepoint Blinding description At the beginning of the study, 21 days after the end of Placebo the intervention Not used Method of measurement Assignment Researcher-made Attitude Survey Questionnaire Parallel Other design features 2 In this study, two questionnaires of attitude-gauging and awareness-raising and a hand-crafted performance Description

2 knowledge Full name of responsible person Timepoint Mr. Jalal Asgharian At the beginning of the study, 21 days after the end of Street address the intervention No.12,Jahanshahi Alley,north of Method of measurement house,Niavaran.sq,Bahonar .st Researcher-mad knowledge-raising questionnaire City Tehran Province 3 Tehran Description Postal code How to handwashing ۱۹۸۵۷۱۳۸۳۴ Timepoint Phone At the beginning of the study, 21 days after the end of +98 21 2613 1550 the intervention Email Method of measurement [email protected] Checklist for handwashing performance evaluation 2 Secondary outcomes Recruitment center empty Name of recruitment center Shahid Soleimani Girls' Elementary School Intervention groups Full name of responsible person Mrs.Leila Bordbar Street address 1 No.18,Mousivand st,Shariati st. Description City The intervention group consists of 19 girls and 19 boys Tehran aged 10-9 years. The training program was conducted in Province 3 sessions of 20-25 minutes and in small groups of 5-3 Tehran people, for 3 consecutive days in a relaxed and suitable Postal code environment. The presence of child health educators was ۱۹۸۵۷۱۳۸۳۴ held. Were used for pre-test and post-test. To collect Phone data, a researcher-made awareness-gauging +98 21 2223 4229 questionnaire, attitudes questionnaire and a hand- Email crafted handwashing inventory were used. The sessions [email protected] included methods Different teaching methods (lectures, group questions and answers) were used. Meanwhile, 3 teaching materials including Whiteboard, PowerPoint, Recruitment center music, and childish poetry were used during the Name of recruitment center teaching. (Combining different educational methods with Shahid Ziaeean girls' Elementary School each other). Full name of responsible person Category Mrs.Baktash N/A Street address Mohsen Arabi st,Evin, Chamran Highway 2 City Tehran Description Province Control group: In the pre-test and post-test stages, a Tehran researcher-madeawareness-gauging questionnaire, Postal code attitudes questionnaire and a hand-crafted handwashing ۱۹۸۵۷۱۳۸۳۴ inventory were studied. This group did not receive any Phone training alone. +98 21 2240 2368 Category Email N/A [email protected] Recruitment centers 4 Recruitment center 1 Name of recruitment center Recruitment center Shahid Ghaffari boys' elementary school Name of recruitment center Full name of responsible person Shahid Hakim boys' elementary School Mrs.Sheikh

3 Street address Full name of responsible person Tofangsazan Alley,Esmaeeli st.Darakeh, Maryam.Mohamadi City Position Tehran Nurse Province Latest degree Tehran Bachelor Postal code Other areas of specialty/work Nursery ۱۹۸۵۷۱۳۸۳۴ Phone Street address +98 21 2240 3585 No.9,Third Dashtestan,.St, Email City [email protected] Tehran Province Sponsors / Funding sources Tehran Postal code 1947947951 1 Phone Sponsor +98 21 2286 3624 Email Name of organization / entity [email protected] University of social welfare and rehabilitation sciences Full name of responsible person Dr. Ameneh Setareh frouzan Person responsible for scientific Street address inquiries University of Rehabilitation Sciences and Social Welfare, Koodakyar deadend,Daneshjoo Contact Blvd,Velenjak. Name of organization / entity City University of social welfare and rehabilitation sciences Tehran Full name of responsible person Province Maryam.Mohamadi Tehran Position Postal code Nurse Latest degree ۱۹۸۵۷۱۳۸۳۴ Phone Bachelor +98 21 2218 0083 Other areas of specialty/work Email Nursery [email protected] Street address Web page address No.9,Third Dashtestan,Pasdaran.St, http://www.uswr.ac.ir/ City Grant name Tehran Grant code / Reference number Province Is the source of funding the same sponsor Tehran organization/entity? Postal code Yes 1947947951 Title of funding source Phone University of social welfare and rehabilitation sciences +98 21 2286 3624 Proportion provided by this source Email 100 [email protected] Public or private sector Public Person responsible for updating data Domestic or foreign origin Domestic Contact Category of foreign source of funding Name of organization / entity empty University of social welfare and rehabilitation sciences Country of origin Full name of responsible person Type of organization providing the funding Maryam.Mohamadi Academic Position Nurse Person responsible for general inquiries Latest degree Bachelor Contact Other areas of specialty/work Name of organization / entity Nursery University of social welfare and rehabilitation sciences Street address

4 No.9,Third Dashtestan,Pasdaran.St, No - There is not a plan to make this available City Justification/reason for indecision/not sharing IPD Tehran The research has been carried out under the condition of Province confidentiality of the information of the subjects. Tehran Study Protocol Postal code No - There is not a plan to make this available 1947947951 Statistical Analysis Plan No - There is not a plan to make this available Phone Informed Consent Form +98 21 2286 3624 No - There is not a plan to make this available Email Clinical Study Report [email protected] No - There is not a plan to make this available Analytic Code Sharing plan No - There is not a plan to make this available Data Dictionary Deidentified Individual Participant Data Set (IPD) No - There is not a plan to make this available

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